← Trials/Trial dossier/NCT06739044

CompletedPhase 3

Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection With Ozempic ® in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Metformin

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

494

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 18.5-35HbA1c 7.5-11%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06739044
Org study IDHDG1901-301

Timeline

Milestones

Study start2023-09-20actual
Primary completion2024-10-11actual
Study first posted2024-12-18actual
Study completion2025-02-21actual
Last update posted2025-07-28actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female, age 18-75 years (both inclusive) at the time of signing informed consent

2. Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg)

3. HbA1c 7.5 - 11.0 % (both inclusive) (screening)

4. HbA1c 7.0 - 10.5 % (both inclusive) (randomisation)

5. BMI 18.5-35 kg/m2 (both inclusive)

Exclusion criteria

1. Other types of diabetes besides Type 2 diabetes

2. A history of acute diabetes complications within 6 months before screening

3. A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis

4. Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)

5. Acute coronary or cerebrovascular event within 3 months before screening or randomisation

6. Heart failure, New York Heart Association (NYHA) class IV

7. Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness

8. Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L

9. Screening calcitonin value ≥ 35 ng/L (pg/mL)

10. Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2

11. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

Change in HbA1c from baseline

Time frame:Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c from baseline

Time frame:Week 20

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose(FPG) from baseline

Time frame:Week 20, Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c ≤ 6.5%

Time frame:Week 20, Week 32

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c ≤ 7.0%

Time frame:Week 20,Week 32

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

C-peptide

Time frame:Week 20, Week 32

descriptive

Secondary/protocol endpoint/low confidence

Insulin

Time frame:Week 20, Week 32

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.